Diabetes mellitus is a disease of major global importance, increasing in frequency at almost epidemic rates, such that the worldwide prevalence in 2006 is 170 million people and predicted to at least double over the next 10-15 years. Diabetes is characterized by a chronically raised blood glucose concentration (hyperglycemia), due to a relative or absolute lack of the pancreatic hormone, insulin.
Treatment of diabetes mellitus requires frequent insulin administration that can be done by multiple daily injections (MDI) with syringe or by continuous subcutaneous insulin injection (CSII) with insulin pumps. In recent years, ambulatory portable insulin infusion pumps have emerged as a superior alternative to multiple daily injections of insulin. These pumps, which deliver insulin at a continuous basal rate as well as in bolus volumes, were developed to liberate patients from repeated self-administered injections, and allow greater flexibility in dose administration.
Several ambulatory insulin infusion devices are currently available on the market. Examples of first generation disposable syringe-type reservoir and tubes were disclosed in U.S. Pat. No. 3,631,847 to Hobbs, U.S. Pat. No. 3,771,694 to Kaminski, U.S. Pat. No. 4,657,486 to Stempfle, and U.S. Pat. No. 4,544,369 to Skakoon. Other dispensing mechanisms have also been discussed, including peristaltic positive displacement pumps, in U.S. Pat. No. 4,498,843 to Schneider and U.S. Pat. No. 4,715,786 to Wolff, the contents of all of which are hereby incorporated by reference in their entireties.
Although these devices represent an improvement over multiple daily injections, they nevertheless all suffer from several drawbacks, including, for example, their large size and weight, caused by their configuration and the relatively large size of the driving mechanisms and of the syringes. These relatively bulky devices have to be carried in a patient's pocket or be attached to the belt. Consequently, the fluid delivery tubes of the infusion set are very long, usually longer than 60 cm, in order to permit needle insertion at remote sites of the body. These uncomfortable bulky devices and long infusion set are rejected by the majority of diabetic insulin users since they disturb regular activities such as sleeping and swimming. Furthermore, the effect of the image projected on the teenagers' body is unacceptable. In addition, the delivery tube excludes some optional remote insertion sites, like buttocks, arms and legs.
To avoid the consequences of long infusion sets, a new concept, referred to as a second generation pump, was proposed. This concept includes a remote controlled skin adherable device with a housing having a bottom surface adapted to contact patient's skin, a reservoir disposed within the housing, and an injection needle adapted to communicate with the reservoir. These skin adherable devices are disposed every 2-3 days similarly to available pump infusion sets. These devices were described, for example, in at least in U.S. Pat. No. 5,957,895 to Sage, U.S. Pat. No. 6,589,229 to Connelly, and U.S. Pat. No. 6,740,059 to Flaherty. Additional configurations of skin adherable pumps were described, for example, in U.S. Pat. No. 6,723,072 to Flaherty and U.S. Pat. No. 6,485,461 to Mason, the contents of all of which are hereby incorporated by reference in their entireties. These devices also have several limitations: they are also bulky and expensive. Their high selling price is due to the high production and accessory costs; the user must discard the entire device every 2-3 days, including the relatively expensive components, such as driving mechanism and electronics.
A third generation dispensing device, such as the Medingo device described in co-pending/co-owned U.S. publication no. 2007-0106218 and International Patent Application No. PCT/IL06/001276, the contents of all of which are hereby incorporated by reference in their entireties, is a miniature portable programmable fluid dispenser that has no tubing and can be attached to the patient skin. It includes of two parts, a disposable part (DP) and a reusable part (RP). After connection of the reusable and the disposable parts, the unified dispensing unit presents a thin profile. The RP contains electronics and other relatively expensive components and the DP contains reservoir. The Medingo device includes a remote control unit that enables data acquisition, programming, and user inputs. An improvement to a skin adherable pump that includes of the two parts is described in co-pending/co-owned U.S. publication no. 2008-0215035 and International Patent Application No. PCT/IL09/000,388, the contents of all of which are hereby incorporated by reference in their entireties. In this application, a device, a system and a method for connection and disconnection of a skin securable pump is disclosed. The system enables the use of a cradle, which is initially adhered to the skin and then a cannula is inserted through the cradle into the body of the user. The cannula, which is a sterilized component, is provided to the patient protected in a cannula cartridge unit. An example for such cannula cartridge unit including a cannula is described in co-pending/co-owned U.S. publication 2008-0319416, the content of which is hereby incorporated by reference. The two-part pump can be consequently connected and disconnected to and from the cradle upon patient discretion. The cannula, cradle, and disposable part are all designed for a single use and are preferably sterilized, to prevent contaminations, irritations, infections and other ill effects. And thus, they should be replaced every several days (e.g. once or twice a week).
Such a device, as described in the above-mentioned patents assigned to Medingo, comprises a number of parts, some of which are disposable. These parts require authentication and identification before and/or during assembling the parts for the following reasons:
1. Intentional or inadvertent reuse of any of the parts might have hazardous consequences on the user. For example, reuse of a cannula may lead to a local, and even systemic infection, reuse of a reservoir may lead to a deficiency of insulin which might result in hyperglycemia. Identification and authentication would allow tracking of the different parts and thus prevent their intentional or inadvertent reuse. Tracking can be done for example, by storing the serial number of the assembled disposable parts in the memory and preventing assembling from disposable parts with the same serial number.2. As part of the quality control of the genuine device, inspections and tests are carried out, and all components and materials must conform to pre-defined specifications. Use of imitations instead of genuine parts might have hazardous consequences on the user because the imitations do not undergo strict quality control and therefore do not conform to the high standards that the genuine parts must meet. For example, use of imitation parts that do not meet the sterility standards may lead to infections. Authentication of the different parts during assembly of the parts may therefore prevent the use of imitations.3. Use of parts whose expiry date has elapsed might have hazardous consequences on the user, for example, the consequence of using insulin after expiry date is deleterious. Determination of the expiry date of the different parts during their assembly may thus prevent the use of parts whose expiry date has passed.4. Assembling of device from parts belonging to different users might also have hazardous consequences on the user. For example, the DPs of different users may comprise different reservoir volumes or different therapeutic agents (e.g. insulin 100 U/mL or 40 U/mL), and faulty assembly may therefore result in fatal consequence due to underdosing or overdosing. Parts identification may prevent assembling of device from RPs and DPs belonging to different users.
Parts identification and/or validation could therefore prevent intentional or inadvertent reuse of any of the parts.